510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K951483 | CPR Micromask | Plasco, Inc. | CBP | Class II | |
| K951025 | Piston Syringe | Pharmacia, Inc. | FMF | Class II | |
| K950566 | Decomat 4656 | Getinge Disinfection AB | LDS | Class II | |
| K945775 | Boehringer Autovac(r) 7900 Series | Boehringer Laboratories, LLC | CAC | Class II | |
| K944595 | Cordis Horizontal-Verical Valve System | Cordis US Corp. | JXG | Class II | |
| K942651 | Biofeedback System for Speech Disorders | Casa Futura Technologies | KTH | Class I | |
| K940003 | Volumet Cd4 + and Cd8 + T Lymphocyte Count Test Kit | Buckman Co., Inc. | GKZ | Class II | |
| K935454 | Dpx Tissue Quantification Output | Lunar Corp. | JAK | Class II | |
| K954526 | Widex Senso Digital (Px) | Widex Hearing Aid Co., Inc. | ESD | Class I | |
| K954484 | Kodak Automixer II Plus | Eastman Kodak Company | IXW | Class II | |
| K954345 | Doosan Dsp 3800 Automatic X-Ray Film Processor | Doosan Corp. | IXW | Class II | |
| K954310 | Bla-800A | Toshiba Medical Systems | KPW | Class II | |
| K954263 | Xe-Lite | Ophthalmic Technologies, Inc. | FTD | Class II | |
| K954252 | Easy Breathing Nasal Strips | Corbett Lair, Inc. | LWF | Class I | |
| K954076 | Midas Rex Drill Attachments & Twist Drills | Midas Rex Pneumatic Tools, Inc. | GET | Class I | |
| K953910 | Philips Bv 300 Series | Philips North America LLC | OXO | Class II | |
| K953889 | American Biosurgical Electrosurgical Bipolar Cable/cord | American Biosurgical, Inc. | GEI | Class II | |
| K953869 | Polysorb II Coated Synthetic Absorbable Suture | United States Surgical, A Division of Tyco Healthc | GAM | Class II | |
| K953602 | Symmetry Small Vessel Balloon Dilatation Catheter | Boston Scientific Corporation | LIT | Class II | |
| K953554 | Noblescope Neuroendoscope System & Accessories | Nobles-Lai Engineering, Inc. | GWG | Class II | |
| K953533 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | DQX | Class II | |
| K953371 | Lumisys Dicom Tooklit | Lumisys, Inc. | LMD | Class I | |
| K953294 | Candela Cryosystem Cs-5 | Candela Corporation | GEH | Class II | |
| K952736 | Percent Oxygen Sensor | Analytical Industries, Inc. | CCL | Class II | |
| K952611 | Sterex Sterile Disposale Electrolysis Needle for Use in Epilation | Sterex Electrolysis Intl., Ltd. | KCW | Class I | |
| K951117 | Lihtan 532 Laser | Buckman Co., Inc. | GEX | Class II | |
| K945983 | Bebig Inactive Ophthalmic Applicators for Iodine 125 Seeds | Bebig Trade, Inc. | KXK | Class II | |
| K943101 | Galvanic Skin Response Device | Global Ent. | GZO | Class II | |
| K954372 | American Dental Products Two Paste Adhesive Orthodontic Bonding System W/fluoride | American Dental Products, Inc. | DYH | Class II | |
| K954341 | Urodynamics Tubing and Infusion Sets | Life-Tech Intl., Inc. | FEN | Class II | |
| K954324 | Snor-X Mouth Guard | Snorex, Inc. | LRK | Class II | |
| K954108 | Modified Versaport | United States Surgical, A Division of Tyco Healthc | GCJ | Class II | |
| K953660 | Plum Xl Infusion Pump (Modification) | Abbott Medical | FRN | Class II | |
| K953468 | Sonogel | Sonotech, Inc. | IYO | Class II | |
| K953382 | Accupump 901 (Model Numbers 50 & 100) | Pharmaceutical Infusion Technologies, Inc. | FRN | Class II | |
| K953359 | Tri-Star Universal I/a Phaco Pak | Tri-Star Ophthalmic | HQC | Class II | |
| K953262 | Qd Bilateral Breast Coil | FUJIFILM Healthcare Americas Corporation | LNH | Class II | |
| K952621 | Eml105 Electrolyte Metabolite Analyzer | Radiometer America, Inc | CGA | Class II | |
| K951753 | Medtec Autoblot 2000 | Medtec LLC | JQW | Class I | |
| K951665 | Pp-Spf1 / Pp-Spf2 | Patriot Products, Inc. | FPA | Class II | |
| K950073 | Mycoplasma Pneumoniae Antibody Latex Agglutination Test System | Shared Systems, Inc. | GSA | Class I | |
| K945445 | Bobes Slit Lamp | Bobes S.A. | HJO | Class II | |
| K935892 | Indurent Gel | Zhermack Dental Production | ELW | Class II | |
| K930530 | Incare Prs 9300 Pelvic Fl Thera Syst/treat Uri Inc | Hollister, Inc. | KPI | Class II | |
| K954520 | Microsurge Veress Needle | Microsurge, Inc. | HET | Class II | |
| K954461 | American Dental Products Core Buildup Paste | American Dental Products, Inc. | EBF | Class II | |
| K954384 | Wound Hydrogel And/or Sterile Wound Hydrogel | Renaissance Pharmaceutical, Inc. | MGQ | Unclassified | |
| K954273 | Cards Q.s. Hcg or Concise Performance Plus Hcg | Ortho-Clinical Diagnostics, Inc. | JHI | Class II | |
| K954080 | Sodem High Speed System | Sodem Diffusion SA | HSZ | Class I | |
| K954041 | G.r.e.e.n. Disposal Container (Note: G.r.e.e.n. Is an Acronym for Glaxo Retrieval Effort for Expended Needles) | Glaxo, Inc. | FMI | Class II |